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GUIDEBOOK
SIEMENS PLM FOR LIFE SCIENCES
Siemens PLM Software for life sciences provides support for end-to-end product
lifecycle management and collaboration on a common platform. Key capabilities
that support medical devices manufacturers include:
Teamcenter is a single source of product and process data that supports
automatic device master record (DMR) creation, linking, maintenance, and
validation against Federal Drug Administration (FDA) guidelines; device history
record (DHR) creation, validation, and revision; and support for integrated
corrective and preventive action (CAPA) complaint tracking, related workflows,
and reporting.
NX supports design and styling requirements, visualization, real-time and
photorealistic rendering, and digital simulation.
Tecnomatix supports manufacturing planning and simulation so that factors
that affect cost, quality and productivity can be evaluated virtually so changes
to product and production designs can be made early in the process.
THE SITUATION
Medical device manufacturers face strict regulatory requirements but are also
pressured to constantly innovate and improve their product to impact patient
outcomes. Like many other manufacturers, those in the medical device industry
are challenged to:
Do more with less. To remain competitive, they must submit more designs for
regulatory approval in less time and reduce process costs while proving their
processes have consistent and repeatable performance.
Reduce time to market. To win in the market, they must be first to deliver on
new patentable devices or innovations, so manufacturing, engineering, quality
control, compliance management, and marketing must all work in concert.
Ensure compliance. Medical device manufacturers must leverage a global
supply chain while ensuring that it meets local regulatory requirements in the
markets where its products will be used.
The most effective way to meet these challenges is to support one version of the
product data from research and development to design to manufacture to
marketing to maintenance, yet few medical device manufacturers today have end-
to-end product lifecycle management systems in place. In fact, most rely more on
disparate silos of information, limited collaboration between teams, and document
or process focused systems.
This Guidebook explores the best practices, fine-tuning tips, and missteps to avoid
for medical device manufacturers to maximize returns from their investment in
Siemens PLM software.
BEST PRACTICES
Companies deploying Siemens PLM software achieve more rapid time to value by
leveraging the solutions ability to support end-to-end management of the medical
device industry product lifecycle. Key best practices include configuring interfaces
for user needs, taking a pilot approach to deployment, training users based on their
roles and profiles, leveraging their vendors industry expertise, and developing a
deployment plan that balances security with openness.
For example, one manufacturer of orthopedic implants needed a virtual process for
customizing surgical plans to suit individual patients. Siemens configured its Web
interface to support a role-based view of the surgical planning process. Surgeons
accessing the application are not exposed to the typical granularity and richness of
a PLM application; they only view the forms and data that they need to provide
input into the implant customization process.
2010 Nucleus Research, Inc. Reproduction in whole or part without written permission is prohibited.
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approach. Taking a learn as you go approach through a pilot can help adjust
small mistakes before they become adoption barriers and provide a controlled
limited environment where the PLM team can validate or adjust their initial
assumptions about how the application can best support PLM efforts.
Starting, for example, with a small group of physicians and engineers with a similar
focus, such as knee replacements, can ensure training and interface requirements
changes are met at a small scale before a broader buildout to a broader user base
and a broader product and therapy portfolio.
Title 21 CFR Part 11 of the Code of Federal Regulations defines the rules under
which electronic records and signatures are considered as reliable as paper records.
This is important to medical manufacturers because it requires them to
institutionalize audits, system validations, and documentation of validation
processes for software and systems that will process electronic data that are
required to be maintained or used to demonstrate FDA compliance. It also applies
to FDA submissions made in electronic format.
2010 Nucleus Research, Inc. Reproduction in whole or part without written permission is prohibited.
Nucleus Research is the leading provider of bottom line-focused technology research and advice.
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Device manufacturers taking the first steps today should be thinking about future
integration goals and ensure their initial efforts can be extended in the future.
Those who have automated some portion of the lifecycle today can identify
additional integration opportunities to reduce costs and streamline business
processes. Teamcenters support for many different CAD authoring tools via its
embedded visualization capacity, JT, can make integrating other teams and
processes possible without expensive and time-consuming retraining.
MISSTEPS TO AVOID
Manufacturers that watch out for common missteps to avoid can keep their PLM
initiatives on the right course, and ultimately maximize their return on investment
from PLM and innovation efforts.
2010 Nucleus Research, Inc. Reproduction in whole or part without written permission is prohibited.
Nucleus Research is the leading provider of bottom line-focused technology research and advice.
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less time and money on customization and have fewer maintenance and support
needs on an ongoing basis.
CONCLUSION
Increasingly, medical device manufacturers seek to have a unified view of their
entire product development lifecycle with the ability to drill down and trace every
product detail. They also drive innovation and research and development efforts
with a strategic focus on improved patient outcomes.
An integrated PLM environment can support the complex needs of medical device
manufacturers while improving cross-team collaboration. Deployed properly,
Siemens PLM Software solutions in the medical device industry can deliver rapid
time to value and enable manufacturers to reduce costs, increase productivity, and
accelerate time to market.
2010 Nucleus Research, Inc. Reproduction in whole or part without written permission is prohibited.
Nucleus Research is the leading provider of bottom line-focused technology research and advice.
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